Filter and Frame Apparatus and Method of Use

ABSTRACT

Provided is a filter apparatus, comprising two or more filter cartridges having a first end with an inlet and screen and a second end with an outlet and screen, and walls to contain a filter media held in a housing for holding the two or more filter cartridges in about the same orientation, and an attachment clamp connected to the housing. Also provided is a housing for holding two or more filter cartridges in about the same orientation and a method of using the filter apparatus and housing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority benefit of U.S. Provisional PatentApplication Ser. No. 61/581,496 filed Dec. 29, 2011, and entitled “DualFilter Cartridge and Frame Apparatus and Method of Use.” The disclosureof the aforementioned Provisional Patent Application Ser. No. 61/581,496is hereby incorporated by reference in its entirety.

BACKGROUND

Filtering toxic compounds from blood has been an area of greatimportance for human health. Filters for adsorption of toxic compoundsfrom blood are known in the art. An example is the use of extracorporealfilters to remove chemotherapeutic drugs from the blood stream duringcancer treatments such as in hepatic chemo saturation therapy. Thistherapy also known as percutaneous hepatic perfusion (PHP) deliversultra-high doses of intra-arterial chemotherapy directly into theisolated liver, saturating both the liver and the tumor cells. The bloodfrom the liver is drained through an isolation-aspiration catheter, andthen directed outside the body to specially designed, and oftenproprietary, filters which reduce the concentration of chemotherapeuticagent before this blood is returned to the body. The potential ofchemosaturation therapy includes: the ability to administer higher dosesof chemotherapeutic agent to a particular organ than could be deliveredwith traditional systemic-intravenous methods while significantlyreducing systemic exposure to the high dose levels.

The filters used to absorb the drug from the blood are incorporated inan extracorporeal circuit. The blood drained from the liver through theisolation aspiration catheter is pumped by a venous bypass pump, such asis used in heart bypass surgery, through a filter or set of filters. Theoutlet of the filter(s) is connected by a tube set to a return catheterinserted in a central vein, through which the cleaned blood is returnedto the patient's circulatory system. In use, the filter(s) are requiredto absorb drug at an efficiency which protect the patient's systemiccirculation from toxic side effects of high drug concentrations. Duringuse with certain drugs such as Melphalan Hydrochloride, poor filtrationcan cause side effects such as anemia, thrombocytopenia, neutropenia,together commonly known as Myelo Suppression. Other drugs at highconcentrations have risk of cardio toxicities if poor filtration failsto reduce systemic concentrations to safe levels.

Filters, pumps, and connecting tubing are typically set up and assembledby a perfusionist, or other technician, prior to the case. Filters maybe clamped or taped to equipment such as IV poles. Multiple filters areoften used to aid efficiency. Many times hardware such as lab clamps canbecome misplaced between cases wasting time to find or forcing thetechnician to improvise a support method at the last minute.

The system, including filters, is connected to catheters for withdrawaland return of blood to the patient. For the entire system all surfacesexposed to body fluids should be kept sterile.

Prior to use, the filters, blood circuit tube set, and pump are preparedfor the procedure. The filters are required to be primed with saline toremove all air from the filter media and to be flushed with saline toremove any fine particulate in the media prior to blood being introducedto the circuit. Proper priming is critical to filter performance.Removing air is necessary to eliminate the potential for air to beinfused into the patient. Also, any air left in the filter reduces thesurface area that blood will contact the filter media thus reducingfilter efficiency.

SUMMARY

The inventors have recognized some problems with prior art filters andprovide herein an apparatus that can solve many of the problems in theprior art.

Where multiple filters are used, the set up procedure can becomecumbersome and unsteady. Technicians will need to use a variety ofhardware to clamp the filters to a support.

If filters were to fall, sterility could be comprised, or catheterscould be dislodged from the patient's body. Additionally, filters couldcrack or leak exposing technical staff and equipment to highconcentrations of toxic compounds such as chemotherapeutic drugs.

If the filters are clamped in place to a support or taped together, itmay be difficult to see the entire filter's circumference and this willhinder the priming process where air bubbles are to be removed.Additionally, if a technician attempts to turn the filters to visualizethe circumference, the mounting method may need to be repeated.

Additionally, during use filters may not see the same resistance to flowif they are angled or set at different heights relative to each other.In accordance with an advantageous feature of some embodiments of theinvention, the filters are held in about the same orientation. This willenable about the same flow resistance in each filter such that bloodflows about equally through each filter. When filtering drugs from bloodit is desirable that each filter provides the same flow resistance sothat blood equally flows through each filter. A reduction in flow in onefilter may allow thrombus formation in the low flow filter which cancontinue to develop until flow is completely stopped in that filter. Theother filter then provides for the majority, and possibly 100% of theflow and filtration. If the flow rate remains the same, and the totalfilter volume is decreased or possibly reduced by 50%, the residencetime will decrease thus reducing filter efficiency. Additionally, havingall flow forced through only one filter may lead to complete saturationof the filter media and limit the filters ability to absorb or filterdrug from the blood. Reduced filter efficiency may lead to an increasein adverse reactions caused by the toxic effects of the chemotherapeuticdrug not adsorbed by the filter.

The inventors recognized that that these problems could be solved byproviding, in some embodiments of the invention, a filter system,apparatus, and method which allows the technician to quickly andsecurely attach the filter housing to a support without the need foradditional hardware. Filter cartridges can be easier to prime and verifyall air is removed if the housing allows the cartridges to be rotated sothat all areas of the filter can be visualized. The system willguarantee that filters have the same flow conditions if the housingmounts all filter cartridges at the same height and orientation.Combining filter cartridges in a rugged frame housing will increasedurability of the product. In some embodiments of the invention,provided herein is a filter system and apparatus wherein the housing ofthe apparatus enables the filter cartridges to be rotated so that allareas of the filter can be visualized, the housing mounts all of thefilter cartridges at the same height and orientation, and the filtercartridges are combined in a rugged frame housing that providesdurability. The combination of these features results in an easy to useand robust filter system that protects the equipment and staff frominadvertent breakage. The apparatus allows for the holding of filtercartridges in about the same orientation. The filter cartridges beingheld in about the same orientation allows for the flow to be about thesame in the different cartridges.

In some embodiments, the invention is a filter system where multiplefilter cartridges are mounted in a single frame housing. The housingincludes a built in clamping mechanism that deploys to allow the filterto be mounted to an IV pole or other suitable and available structure inan operating room. A technician can simply open the sterile suppliedfilter system, deploy the mounting mechanism, and clamp the assembly toan available IV pole or other supporting member available in theoperating room. The housing is mechanically strong and provides a verysolid attachment to the support with no risk of falling and no need toimprovise a clamping means. The cartridge is allowed to rotate withinthe housing during priming so that all areas of the filter can bevisualized to verify air has been removed. The housing also insures thatboth filters are mounted in the same orientation and height whichguarantees that each filter sees the same flow conditions.

In some embodiments, provided is a filter apparatus, comprising two ormore filter cartridges having a first end with an inlet and screen and asecond end with an outlet and screen, and walls to contain a filtermedia, a housing for holding the two or more filter cartridges in aboutthe same orientation, and an attachment clamp connected to the housing.In some embodiments the housing comprises an upper plate and a lowerplate for holding the two or more filter cartridges, the upper plate andthe lower plate comprising openings for rotatably engaging the two ormore filter cartridges, and one or more support elements connecting theupper plate and the lower plate. By providing for the rotation of thefilter cartridges, a medical professional can examine the filter mediain the where the cartridges are made of a transparent material.Examination of the filter media is often useful in various stages ofmedical procedures that comprise filtration such as when the filtermedia needs to be primed for filtration. Priming often comprises removalof trapped gas bubbles in the filter media and being able to noticewhether bubbles are trapped in the filter media will help facilitate thepriming process.

In some embodiments of the filter apparatus, the attachment clamp isconnected to one or more of the one or more support elements. In someembodiments, the one or more support elements comprise a combination ofrods and support plates. In some embodiments the attachment clamp is apole clamp.

In some embodiments of the filter apparatus the walls that contain thefilter media comprise a cartridge tube. In some embodiments, thecartridge tube is transparent.

In some embodiments of the filter apparatus the inlet and outletcomprise an inlet connector and an outlet connector. In someembodiments, the outlet connector is connected to the cartridge tube byan outlet flange. In some embodiments, the outlet flange is conical.

In some embodiments, the inlet connector is connected to the cartridgetube by an inlet flange.

In some embodiments of the filter apparatus, the filter media comprisesactivated carbon. In some embodiments, the filter media is hydrogelcoated activated carbon.

In some embodiments of the filter apparatus, the walls to contain thefilter media define a cylindrical shape.

In some embodiments, provided is a filter apparatus, comprising twofilter cartridges having a first end with an inlet comprising an inletconnector connected to the cartridge tube by an inlet flange and screenand a second end with an outlet comprising an outlet connector andconnected to the cartridge by a conical outlet flange and screen, and atransparent cartridge tube to contain a filter media, a housing forholding the two filter cartridges in about the same orientationcomprising an upper plate and a lower plate for holding the two filtercartridges, the upper plate and the lower plate comprising openings forrotatably engaging the two filter cartridges, support elementscomprising support plates and rods connecting the upper plat to thelower plate, and a pole clamp connected to the support plates.

In some embodiments, the filter apparatus the cartridge tubes of thefilter apparatus are comprised of a transparent material selected from apolysulfone, a polycarbonate, a polypropylene, an acrylic, orcombinations thereof.

In some embodiments, provided is a housing for holding two or morefilter cartridges in about the same orientation, comprising a connectedstructure comprising an upper plate and a lower plate, the upper plateand the lower plate comprising openings for rotatably engaging the twoor more filter cartridges, one or more support elements connecting theupper plate and the lower plate, and an attachment clamp connected tothe housing.

In some embodiments, a method is provided for setting up a filterapparatus for a hemo filtration therapy, comprising attaching a filterapparatus according to claim 1 to an IV pole and rotating the cartridgesto observe if there are lodged bubbles in the filter media. In someembodiments of the method, the housing is a connected structure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view from the front of dual filter cartridgesmounted in a single frame;

FIG. 2 shows a top view of dual filter cartridges mounted in a singleframe with the mounting means deployed for connection;

FIG. 3 shows a bottom view of dual filter cartridges mounted in a singleframe with the mounting means deployed for connection;

FIG. 4 shows a front view of dual filter cartridges mounted in a singleframe;

FIG. 5 shows a perspective view from the back of dual filter cartridgesmounted in a single frame with mounting means stowed for packaging;

FIG. 6 shows a back view of dual filter cartridges mounted in a singleframe with mounting means stowed for packaging;

FIG. 7 shows a side view of dual filter cartridges mounted in a singleframe with the mounting means deployed for connection;

FIG. 8 shows an exploded view of dual filter cartridges and housing;

FIG. 9 shows a perspective view from back of dual filter cartridgesmounted in a single frame with mounting means deployed and connected toa pole such as an IV pole; and

FIG. 10 shows dual filter cartridges mounted in a single frame in anextracorporeal blood filtration set up incorporated into a percutaneoushepatic perfusion procedure.

DETAILED DESCRIPTION

In some embodiments, a filter cartridge can be made in the following wayby assembling lower inlet flange 12 to the cartridge tube 11, to theupper outlet flange 18. An inlet connector 15 is connected to lowerinlet flange 12. In some embodiments, an inlet screen (not shown) isincorporated at the inside end of a cartridge tube 11 at the jointbetween the lower inlet flange 12 and cartridge tube 11. In someembodiments, filter media can be added to the assembly by filling theinside volume of cartridge tube 11. An outlet connector 19 is connectedto upper outlet flange 18. An outlet screen (not shown) is incorporatedat the inside ends of cartridge tube 11 at the joint between the upperoutlet flange 18 and cartridge tube 11. The screens provide a means tokeep filter media (not shown), typically small spheres or beads, withinthe filter cartridge while allowing blood to flow into, through, and outof the filter. The screens can be formed of a suitable polymer with a200-400 micron mesh. The flanges 12 and 18 and tube 11 can be formedfrom any suitable transparent plastic such as a polysulfone, apolycarbonate, a polypropylene, an acrylic, and the like. In someembodiments, combinations of these transparent materials can be used.The connections between components can be joints formed by adhesive suchas two part epoxy or ultraviolet light curing epoxy, or the joints canbe heat welded by means such as radio frequency welding, inductionwelding, or ultrasonic welding.

The housing is assembled from structural components. In someembodiments, lower plate 1 is attached to six tie rods 7 with six tamperproof flat head cap screws 10. In some embodiments, center supportplates 2 and 3 are assembled with the pole clamp 5 to create adeployable mounting mechanism. Pivot pin 4 is pressed fit into centersupport plate 2, and is passed through pole clamp 5 and is press fitinto opposite center support plate 3. Three stop pins 6 are pressed intoreceiving holes in center support plate 2 and 3. Two stop pins 6 formthe stop for the pole clamp 5 deployed position, one stop pin 6 form thestop for the stowed position. Clamp knob 8 has a threaded shaft that isscrewed through pole clamp 5. The sub assembly of center support plates2 and 3, pins 4 and 6, and pole clamp 5 and knob 8 creates thedeployable mounting mechanism. The sub assembly is then attached tolower plate 1 with four tamper proof flat head cap screws 10. Herein,item 1 is used for both upper plate and lower plate as the plates arethe same part. Face plate 25 is inserted into grooves in the centersupport plates 2 and 3 and slid towards the lower plate 1 until itcontacts the lower plate 1. O ring 9 can be formed from an elastomericmaterial such as Silicone or Viton. One O ring 9 is added to the top ofeach cartridge assembly at the upper outlet flange 18. A cartridgeassembly with O ring 9 is inserted into each side of the frame housingbetween tie rods 7 and center support plates 2 and 3. Upper plate 1 isplaced on top of the assembly and secured to the tie rods 7 and centersupport plates 2 and 3 with ten tamper proof flat head cap screws 10.The O rings 9 are captured between upper plate 1 and upper outletflanges 18 such that the cartridges can smoothly rotate within thehousing frame without being loose or creating excessive compression ofthe cartridge within the housing frame.

In some embodiments of the invention, the filter system can be packaged,labeled, and sterilized by the manufacturer. It can be shipped to thecustomer alone or as a component of a comprehensive kit containing allcomponents needed to perform a procedure. Once in use the techniciansetting up the system will open the packaging while maintainingsterility of inlet connector 15 and outlet connector 19. As shown inFIG. 9, the pole clamp 5 can be deployed from its storage positionbetween center support plates 2 and 3. The pole clamp 5 can rotatearound pivot pin 4 and contact stop pins 6, which limits the clamprotation to a perpendicular orientation. The pole clamp 5 can be placedaround an available IV pole or similar available structure in theoperating room. The frame is secured to a pole by tightening clamp knob8 on to the pole.

The technician and physician team can then assemble the system connecttubing between the filter system and other components which make up acomplete circuit such as pump, saline supply bags, and flow ratemonitor. The tube set which connects to the filter uses rotatableconnectors to connect to inlet connectors 15 and outlet connector 19.All components are primed and flushed with saline. The technician willslowly fill the filters with saline from the bottom up allowing air toescape from the top. Due to the high surface area of some filter media,air will often be trapped in the filter cartridge and will need to becoaxed to leave by slowly flushing saline through the filter whiletapping the filter cartridge walls to break the air bubbles free. Toinsure that all air has been removed the technician can rotate thecartridge within the frame to view the entire circumference of thecartridge. Once the filters are primed, the final connections can bemade to the isolation aspiration catheter which acts as a supplycatheter and the venous return catheter, already placed in location inthe patient as shown in FIG. 10. The procedure can then be performedwith a secure and safe system.

1-20. (canceled)
 21. A kit for delivering a chemotherapeutic agent to aliver of a patient, comprising: an isolation-aspiration catheter, and afilter apparatus comprising two or more filter cartridges mounted in asingle frame housing, wherein the housing comprises an upper plate and alower plate for holding the two or more filter cartridges in about thesame orientation, the upper plate and the lower plate comprisingopenings for rotatably engaging the two or more filter cartridges, andan attachment clamp.
 22. A kit according to claim 21, further comprisinga venous return sheath
 23. A kit according to claim 21, furthercomprising a venous return catheter.
 24. A kit according to claim 21,further comprising a hepatic arterial infusion catheter.
 25. A kitaccording to claim 21, further comprising melphalan hydrochloride.
 26. Akit according to claim 21, further comprising an extracorporeal circuit.27. A kit according to claim 21, wherein the two or more filtercartridges extend through the openings of the upper plate, the lowerplate, or the upper and lower plates.
 28. A kit according to claim 21,wherein the filter apparatus is a dual cartridge.
 29. A kit according toclaim 21, wherein the isolation-aspiration catheter is a double ballooncatheter.
 30. A kit according to claim 21, wherein the attachment clampis a pole clamp.
 31. A kit for delivering a chemotherapeutic agent to aliver of a patient, comprising: an isolation-aspiration catheter, and afilter apparatus, comprising two or more filter cartridges having afirst end with an inlet and screen and a second end with an outlet andscreen, and walls to contain a filter media; a housing comprising anupper plate and a lower plate for holding the two or more filtercartridges in about the same orientation, the upper plate and the lowerplate comprising openings for rotatably engaging the two or more filtercartridges, and one or more support elements connecting the upper plateand the lower plate.
 32. A kit according to claim 31, further comprisinga venous return sheath.
 33. A kit according to claim 31, furthercomprising a venous return catheter.
 34. A kit according to claim 31,further comprising a hepatic arterial infusion catheter.
 35. A kitaccording to claim 31, further comprising melphalan hydrochloride.
 36. Akit according to claim 31, further comprising an extracorporeal circuit.37. A kit according to claim 31 further comprising a pole clampconnected to the housing.
 38. A kit according to claim 31, wherein thetwo or more filter cartridges extend through the openings, the upperplate (1) and the lower plate (1).
 39. A kit according to claim 31,wherein the walls to contain the filter media comprise a cartridge
 40. Akit according to claim 31, wherein the filter media comprises activatecarbon.
 41. A kit according to claim 31, wherein the filter media ishydrogel coated activated carbon.
 42. A kit of parts according to claim31, wherein the isolation-aspiration catheter is a double ballooncatheter.
 43. A kit for delivering a chemotherapeutic agent to a liverof a patient, comprising: an isolation aspiration catheter; a filterapparatus comprising two or more filter cartridges each filter cartridgecomprising a first end with an inlet, and a first screen, a second endwith an outlet and a second screen, and walls configured to contain afilter media and comprising a cartridge tube, wherein the outlet of eachfilter cartridge is connected to an outlet connector by an outletflange; a housing comprising an upper plate and a lower plate orientedsubstantially parallel to each other and configured to hold the two ormore filter cartridges in about the same orientation, the upper plateand the lower plate each defining two or more openings to which the twoor more filter cartridges are rotatably coupled and wherein the outletflange connected to each outlet connector extends through the two ormore openings of the upper plate, and an attachment clamp connected tothe housing.
 44. A kit for delivering a chemotherapeutic agent to aliver of a patient according to claim 43, wherein the housing furthercomprises one or more support elements connecting the upper plate andthe lower plate.
 45. The filter apparatus of claim 43, wherein thecartridge tube is comprised of a transparent material selected from thegroup consisting of a polysulfone, a polycarbonate, a polypropylene andan acrylic.
 46. The filter apparatus of claim 43, wherein the filtermedia is hydrogel coated activated carbon.
 47. A kit according to claim43, further comprising a venous return sheath.
 48. A kit according toclaim 43, further comprising a venous return catheter.
 49. A kitaccording to claim 43, further comprising a hepatic arterial infusioncatheter.
 50. A kit according to claim 43, further comprising melphalanhydrochloride.
 51. A kit according to claim 43, further comprising anextracorporeal circuit.
 52. A kit according to claim 43, wherein thefilter apparatus is a dual cartridge.
 53. A kit according to claim 43,wherein the isolation-aspiration catheter is a double balloon catheter.54. A percutaneous hepatic perfusion (PHP) system for deliveringhigh-dose chemotherapy to the liver, comprising: an isolation-aspirationcatheter; and a filter apparatus comprising two or more filtercartridges mounted in a single frame housing, wherein the housingcomprises an upper plate and a lower plate for holding the two or morefilter cartridges in about the same orientation, the upper plate and thelower plate comprising openings for rotatably engaging the two or morefilter cartridges, and an attachment clamp.
 55. A percutaneous hepaticperfusion (PHP) system for delivering high-dose chemotherapy to theliver according to claim 54, further comprising a venous return sheath56. A percutaneous hepatic perfusion (PHP) system for deliveringhigh-dose chemotherapy to the liver according to claim 54, furthercomprising a venous return catheter
 57. A percutaneous hepatic perfusion(PHP) system for delivering high-dose chemotherapy to the liveraccording to claim 54, further comprising a hepatic arterial infusioncatheter.
 58. A percutaneous hepatic perfusion (PHP) system fordelivering high-dose chemotherapy to the liver according to claim 54,further comprising an extracorporeal circuit.